PATIENTS MAY JOIN TEST OF NEW ALZHEIMER'S DRUG

An experimental drug that some studies indicate helps Alzheimer's patients think and function better has become available in Palm Beach County through a limited number of physicians.

Tacrine, or THA, is being reviewed by the Food and Drug Administration, which in July asked the manufacturer, Warner-Lambert Co., to conduct further trials with higher doses for longer terms.

The FDA's peripheral and central nervous system drugs advisory committee also recommended that THA be offered to Alzheimer's patients around the country under an "expanded access" program -- but only if carefully controlled clinical studies continued. The agency accepted the recommendation in December.

"We will be making the drug available to 15,000 patients through 1,500 neurologists, psychiatrists and geriatricians," Warner-Lambert spokesman Peter Wolf said.

"Our intent is to get the drug to people, as well as to collect safety data on any major side effects reported by the doctors," Wolf said. THA has been linked to damage to liver function, and this will be monitored carefully by participating doctors, he said.

"It would be superlative if we can help some Alzheimer's patients maintain their dignity and their ability to function through the use of THA," said Dr. Ronald Wilk, a Boca Raton neurologist who was selected to participate in the expanded access program.

Wilk's partners at the Neuroscience Center of Boca Raton, Harold Friend and Richard Bailyn, also are participating, and together they will accept as many as 150 patients. The Palm Beach Neurological Group in Palm Beach Gardens also is enrolled in the program.

"There is really nothing available on the commercial market to help these patients," Wilk said. "A drug like this not only may be able to help the patients, but also make it easier for relatives to take care of them at home."

Alzheimer's disease afflicts as many as 4 million people in the United States, striking more than 10 percent of the population over age 65 and nearly half those 85 or older.

Eventually, many Alzheimer's patients cannot care for themselves and then require constant supervision, which often causes an emotional and financial toll on the caregivers. Alzheimer's also is the fourth leading cause of death among American adults, killing 100,000 a year.

According to a protocol established by the Parke-Davis division of Warner- Lambert, potential THA patients must have a mild-to-moderate form of Alzheimer's disease.

"A typical mild case would be someone who is starting to experience difficulty with memory, recognizing faces, spelling, dressing and keeping an accurate checkbook," Wilk said. "A moderate case is characterized by a patient's difficulty in interacting with society."

Alzheimer's patients have a reduced level of the chemical choline in the brain, and THA appears to work by helping the body maintain a higher level of the chemical, he said.

A thorough neurological examination is required for a patient to be accepted in the program. Diagnostic procedures required include blood tests; magnetic resonance imaging (MRI); an electroencephalogram (EEG); and a psychological test.

The results are sent via computer to Parke-Davis, and doctors are notified within a few days if the patient has been accepted.

The cost for testing can range from $200 to $2,000, depending on how much has been done previously, Wilk said. Medicare and private insurance often pay their share of the costs because the tests are diagnostic and not related directly to the experimental drug program.

"We can use a lot of the data supplied to us by the patient's family physician or another neurologist," Wilk said. "If a required test was performed recently, there is a good chance we will not have to repeat it."

Those with evidence of liver disease, bleeding ulcers or asthma most likely would be excluded, he said.

After the patient is accepted, and after a relative signs a consent form that warns of the possible side effects, the drug is sent by Parke-Davis to the caregiver. Participating doctors do not handle the medication.

The first six weeks' treatment with the drug, which would be marketed as Cognex, is free. After that, Wolf said, the cost is about $100 a month.

In addition, patients are required to have a weekly blood test to monitor liver enzyme levels. The test at the neuroscience center costs $18.50. Patients also must see the doctor roughly every six weeks. The neuroscience center charges $53.50.

Medicare or private insurance may not cover these costs because they are directly related to the use of an experimental drug.

Wilk said six patients are receiving THA, and another nine are candidates for the program. About 135 spaces remain at the center.

"This is a terrible, frustrating disease," Wilk said. "For the first time, something significant is available to help. We hope the drug proves to be a success. There is no better feeling in the world than to have a grateful patient."

TO LEARN MORE

Warner-Lambert has established a toll-free phone number for caregivers who want to learn more about THA and the expanded access program. The number: 1-800-452-6463. A health information specialist will explain the nature of the drug, dosages, results of studies and costs associated with the program. The Neuroscience Center of Boca Raton, which is participating in the program, is at 392-8533. The Palm Beach Neurological Group in Palm Beach Gardens, which also is participating, is at 694-1010.